Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06325280
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-03-05
Brief Title:
Exercise MRI to Evaluate Cardiorespiratory Fitness in Children with Heart Disease
Sponsor:
University of Alberta
Organization:
University of Alberta
Study Overview
Official Title:
Utilizing Exercise Cardiovascular and Skeletal Magnetic Resonance Imaging to Evaluate Factors Associated with Cardiorespiratory Fitness in Children with Acquired and Congenital Heart Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There are many barriers to heart-healthy lifestyles in pediatric patients with acquired and congenital heart disease Investigators want to further understand how participants heart and skeletal muscles work together during exercise and evaluate the impact on cardiac function To do this the investigators will use magnetic resonance imaging MRI to scan the heart and skeletal muscles during exercises to assess blood flow oxygenation and function
Detailed Description:
Exercise cardiac MRIs are the non-invasive gold standard for assessing biventricular function during exercise While exercise MRI has not been previously studied in pediatric HTRs it has been effectively utilized in children with single ventricle congenital heart disease The purpose of this study is to fully understand the cardiac adaptations induced by exercise training
Primary objective Evaluate the association between exercise MRI cardiac and skeletal muscle measures and cardiorespiratory fitness in pediatric acquired HTRx and CHD participants
Hypothesis Cardiac adaptations to exercise and skeletal muscle functioning will be positively associated with measured CRF in CHD patients and those post-transplant
Secondary objective Evaluate changes in exercise MRI measures of cardiac and skeletal muscle function following a 12-week high-intensity interval training HIIT exercise protocol in children with acquired and congenital heart disease
Hypothesis a 12-week HIIT intervention will result in improvements in cardiac and skeletal muscle responses to exercise
This will be a single-center prospective observational study
Participants will include 10-18 year old pediatric heart transplant recipients HTR and congenital heart disease CHD patients followed at the Stollery Childrens Hospital
Participants will undergo cardiopulmonary exercise testing CPET using a cycle ergometer and standardized protocols On a separate day within 2 weeks of the testing participants will return and undergo a standard cardiac MRI to assess resting ventricular structure and function They will then complete an exercise cardiac MRI assessment using an MRI-compatible stepping ergometer
Participants and their parent will also be asked to complete questionnaires to determine their feelings towards exercise and physical activity
As this will be a single-center study The analysis will be largely exploratory and the sample size will be determined based on the available patient population Based on a review of potentially eligible participants at our center the investigators anticipate recruiting 10 participants post-HTR and 10 CHD participants to evaluate the primary objective As the secondary objective changes in cardiac and skeletal muscle MRI measures requires repeated assessments and involvement in the MedBIKE HIIT trial recruitment to address this objective may be lessened the investigators thus anticipate recruiting 6 participants post-transplant and 6 participants with CHD The statistical analysis will be carried out in collaboration with the Women and Childrens Health Research Institute WCHRI biostatistics team accounted for in budget Differences in MRI and CPET measures among participants and changes in the measures Objective 2 will be evaluated by independent t-tests or Mann-Whitney tests for continuous variables and chi-square or Fishers exact tests for categorical variables Pearson correlations will be used to evaluate associations between VO2peak and other CPET measures of CRF and measures of cardiac function and output and peripheral muscle oxygen extraction
Primary objective Evaluate the association between exercise MRI cardiac and skeletal muscle measures and cardiorespiratory fitness in pediatric acquired HTRx and CHD participants
Hypothesis Cardiac adaptations to exercise and skeletal muscle functioning will be positively associated with measured CRF in CHD patients and those post-transplant
Secondary objective Evaluate changes in exercise MRI measures of cardiac and skeletal muscle function following a 12-week high-intensity interval training HIIT exercise protocol in children with acquired and congenital heart disease
Hypothesis a 12-week HIIT intervention will result in improvements in cardiac and skeletal muscle responses to exercise
This will be a single-center prospective observational study
Participants will include 10-18 year old pediatric heart transplant recipients HTR and congenital heart disease CHD patients followed at the Stollery Childrens Hospital
Participants will undergo cardiopulmonary exercise testing CPET using a cycle ergometer and standardized protocols On a separate day within 2 weeks of the testing participants will return and undergo a standard cardiac MRI to assess resting ventricular structure and function They will then complete an exercise cardiac MRI assessment using an MRI-compatible stepping ergometer
Participants and their parent will also be asked to complete questionnaires to determine their feelings towards exercise and physical activity
As this will be a single-center study The analysis will be largely exploratory and the sample size will be determined based on the available patient population Based on a review of potentially eligible participants at our center the investigators anticipate recruiting 10 participants post-HTR and 10 CHD participants to evaluate the primary objective As the secondary objective changes in cardiac and skeletal muscle MRI measures requires repeated assessments and involvement in the MedBIKE HIIT trial recruitment to address this objective may be lessened the investigators thus anticipate recruiting 6 participants post-transplant and 6 participants with CHD The statistical analysis will be carried out in collaboration with the Women and Childrens Health Research Institute WCHRI biostatistics team accounted for in budget Differences in MRI and CPET measures among participants and changes in the measures Objective 2 will be evaluated by independent t-tests or Mann-Whitney tests for continuous variables and chi-square or Fishers exact tests for categorical variables Pearson correlations will be used to evaluate associations between VO2peak and other CPET measures of CRF and measures of cardiac function and output and peripheral muscle oxygen extraction
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None